BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPACELABS ULTRAVIEW SL COMMAND MODULE

    MDR report key: 5512552 · Received March 19, 2016

    Report

    Report Number
    3010157426-2016-00022
    Event Type
    Injury
    Date Received
    March 19, 2016
    Date of Event
    February 18, 2016
    Report Date
    May 7, 2016
    Manufacturer
    SPACELABS HEALTHCARE INC.
    Product Code
    DSI
    PMA / PMN Number
    K103142
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    SPACELABS IS EVALUATING THIS OCCURRENCE AND WILL FILE A SUPPLEMENTAL REPORT ONCE OUR EVALUATION IS CONCLUDED.

    Additional Manufacturer Narrative · 1

    ONSITE INVESTIGATION OF THE INVOLVED DEVICES CONDUCTED BY A SPACELABS REPRESENTATIVE CONFIRMED THAT THE EQUIPMENT PERFORMED TO SPECIFICATIONS. THE INVESTIGATION WAS WITNESSED BY A FACILITY REPRESENTATIVE. THE PATIENT RETROSPECTIVE DATABASE PROVIDED BY THE FACILITY WAS REVIEWED BY A SPACELABS LEAD SOFTWARE ENGINEER. THERE IS EVIDENCE THAT THE MONITOR DETECTED A LOW HEART RATE CONDITION AND GENERATED BOTH MEDIUM AND HIGH PRIORITY ALARMS AS APPROPRIATE. BASED UPON THE INVESTIGATION, WE HAVE CONCLUDED THAT THE DEVICE DID NOT MALFUNCTION. THIS INVESTIGATION IS CONSIDERED COMPLETE AND THE ISSUE CLOSED.

    Description of Event or Problem · 1

    SPACELABS RECEIVED A REPORT THAT NO ALARM SOUNDED OR PRINTED AT THE BEDSIDE OR CENTRAL MONITORS WHEN THE PATIENT'S HEART RATE DROPPED TO 20 BPM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    168425 SPACELABS ULTRAVIEW SL COMMAND MODULE ULTRAVIEW SL MULTIPARAMETER MODULE DSI SPACELABS HEALTHCARE INC. 91496

    Patients

    Seq Age Sex Outcome Treatment
    1 Other